Overview

Welcome to the FOUNDATION Study Website

Aim

The aim is to see if a trial could be conducted: this study will work with adults with
severe-to-profound deafness and cochlear
implant users to understand whether patients would be willing to take part in the
bilateral
trial recommended by NICE

Background

A cochlear implant is a device that can restore some hearing to a deaf ear. In the UK,
cochlear implantation is the standard
treatments for adults with ‘severe to profound’ deafness. This level of deafness means
that
without a cochlear implant these adults have difficulty understanding what people are
saying
even when they wear hearing aids. They have difficulty using the telephone and may be
unable
to hear important sounds like alarms, doorbells and traffic.

The NHS provides a cochlear implant for one ear even though these adults are deaf in
both ears. Two cochlear implants could
help them understand speech in noisy environments, know where to look to see who is
talking
and avoid hazards outdoors.

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Trial Summary

What is the FOUNDATION study?

FOUNDATION is a
feasibility study looking to inform a potential future clinical trial. This
future clinical
trial will compare a group of patients who have received one cochlear implant
(unilateral
implantation) with a group of patients who have received two cochlear implants
(bilateral
implantation). The participants in this future study will be assessed to see whether or
not
there is a measurable difference in quality of life between having one cochlear implant
and
having two.

The FOUNDATION study involves focus groups, questionnaires and an online survey which
will be
used to inform us as to whether or not a future study is feasible*.

Why are we doing it?

Currently, standard of care in the NHS for those with severe to profound deafness is
unilateral cochlear implantation. The
National Institute for Health and Care Excellence (NICE) have agreed that providing two
cochlear
implants, instead of just one, can provide additional benefits. Before this future
trial
can be conducted we need to gather further evidence to show that these additional
benefits
are worth the additional cost of providing the second cochlear implant. We will not
know
if two implants provide a greater benefit than just one implant unless we compare two
groups
of people, one group with just one implant and one group who have received two
implants.

What has happened so far?

Focus groups took place in July 2017 and have helped inform the FOUNDATION study,
please see our ‘Timeline’ page for further
information.

Our online survey was open between March and May 2018, we had a fantastic response to
this with nearly 150 participants completing the survey.

What is involved if I want to take part in the
Foundation study?

Online Survey:

There is an online survey where candidates for cochlear implantation, cochlear implant
users
and healthcare professionals can complete a series of questions which will inform the
future
study. The link here will take you to this survey: (Link here if survey still open).

Quality of Life Questionnaires:

There are three centres involved in the study, patients will be asked if they are
willing to
complete a series of questionnaires during routine clinical appointments before and
after
unilateral cochlear implantation. This information will help the research team to
understand
the change in quality of life pre and post cochlear implantation. Questionnaires will
take
approximately 15 minutes to complete. The information gathered will help to inform the
future
clinical trial. There is further information on each centre and the teams involved on
the
"Recruiting Centres" page.

* You can read about each part of the study in more detail on the "Trial Timeline" page.

Registrations

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Recruiting Centres

Trial Timeline

Focus Groups

In July 2017 two patient-led focus groups were held to help us to design Foundation.
The contribution of the focus groups
has been extremely useful.

Online Survey

The online survey has now closed, participation was fantastic with over 130 responses

Part of the study involves an online survey; those who are candidates for a cochlear
implant
(CI), a current CI user or a healthcare professional will be asked a series of
questions
in order to gain information for a potential future study. All answers to this survey
will
be anonymous and no personal data is collected. The information provided will be used
to
inform healthcare professionals as to whether or not a future clinical trial is
feasible.

Multi centre screening exercise

Recruitment to the Multi-Centre Screening Exercise has now closed to recruitment. 65
participants were recruited to take part in the multi-centre screening exercise

This part of the study involves patients who have been referred to a cochlear implant
centre
being asked if they would be able to complete a series of questions. The information
gathered
will be anonymous and will inform the potential future study. Patient feedback is very
important
to us and we appreciate all the time and effort you will afford the study.

Care Pathway Working Group

The care pathway for cochlear implants has changed significantly since guidance on
cochlear implantation was issued in the UK back in 2009. This part of the study will
work with those who deliver cochlear implant services around the UK to gather
information on what services look like today and how they operate. By gathering up to
date information on how care is delivered, by whom, and how often, we can make much
more accurate conclusions about whether bilateral implantation may be a good use of
limited healthcare resources.

Contact

Please feel free to contact the FOUNDATION study team by any of the means
below: